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LEVITRA Drug Profile

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Which patents cover Levitra, and what generic alternatives are available?

Levitra is a drug marketed by Bayer Hlthcare and is included in one NDA. There are four patents protecting this drug and three Paragraph IV challenges.

This drug has one hundred and forty-three patent family members in fifty-two countries.

The generic ingredient in LEVITRA is vardenafil hydrochloride. There are six drug master file entries for this compound. Nine suppliers are listed for this compound. Additional details are available on the vardenafil hydrochloride profile page.

Summary for LEVITRA

International Patents:	143
US Patents:	4
Applicants:	1
NDAs:	1
Suppliers / Packagers:	5
Bulk Api Vendors:	131
Clinical Trials:	24
Patent Applications:	1,823
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for LEVITRA
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for LEVITRA
DailyMed Link:	LEVITRA at DailyMed

Pharmacology for LEVITRA

Drug Class	Phosphodiesterase 5 Inhibitor
Mechanism of Action	Phosphodiesterase 5 Inhibitors

Synonyms for LEVITRA

1-((3-(3,4-Dihydro-5-methyl-4-oxo-7-propylimidazo(5,1-f)-as-triazin-2-yl)-4-ethoxyphenyl)sulfonyl)-4-ethylpiperazine

1193386-64-9

2-(2-Ethoxy-5-((4-ethylpiperazin-1-yl)sulfonyl)phenyl)-5-methyl-7-propylimidazo(5,1-f)triazin-4(3H)-one

2-(2-ethoxy-5-((4-ethylpiperazin-1-yl)sulfonyl)phenyl)-5-methyl-7-propylimidazo[5,1-f][1,2,4]triazin-4(1H)-one

2-(2-ethoxy-5-((4-ethylpiperazin-1-yl)sulfonyl)phenyl)-5-methyl-7-propylimidazo[5,1-f][1,2,4]triazin-4(1H)-one hydrochloride

2-(2-ethoxy-5-((4-ethylpiperazin-1-yl)sulfonyl)phenyl)-5-methyl-7-propylimidazo[5,1-f][1,2,4]triazin-4(1H)-one hydrochloride trihydrate

2-(2-Ethoxy-5-(4-ethyl-piperazine-1-sulfonyl)-phenyl)-5-methyl-7-propyl-3H-imidazo(5,1-f)(1,2,4)triazin-4-one, hydrochloride

2-(2-Ethoxy-5-(4-ethylpiperazin-1-yl-1-sulfonyl)phenyl)-5-methyl-7-propyl-3H-imidazo(5,1-f)(1,2,4)triazin-4-one

2-(2-Ethoxy-5-(4-ethylpiperazin-1-yl-1-sulfonyl)phenyl)-5-methyl-7-propyl-3H-imidazo(5,1-f)(1,2,4)triazin-4-one dihydrochloride

2-[2-ethoxy-5-(4-ethyl-piperazine-1-sulphonyl)-phenyl]-5-methyl-7-propyl-3H -imidazo[5,1-f][1,2,4]triazine-4-one dihydrochloride

2-[2-Ethoxy-5-(4-ethyl-piperazine-1-sulphonyl)-phenyl]-5-methyl-7-propyl-3H-imidazo[5,1-f](1,2,4]triazine-4-one dihydrochioride

2-[2-ethoxy-5-(4-ethyl-piperazine-1-sulphonyl)-phenyl]-5-methyl-7-propyl-3H-imidazo[5,1-f][1,2,4]triazin-4-one

2-[2-ethoxy-5-(4-ethyl-piperazine-1-sulphonyl)-phenyl]-5-methyl-7-propyl-3H-imidazo[5,1-f][1,2,4]triazin-4-one hydrochloride

2-[2-ethoxy-5-(4-ethyl-piperazine-1-sulphonyl)-phenyl]-5-methyl-7-propyl-3H-imidazo[5,1-f][1,2,4]triazine-4-one

2-[2-Ethoxy-5-(4-ethyl-piperazine-1-sulphonyl)-phenyl]-5-methyl-7-propyl-3H-imidazo[5,1-f][1,2,4]triazine-4-one dihydrochioride

2-[2-ethoxy-5-(4-ethyl-piperazine-1-sulphonyl)-phenyl]-5-methyl-7-propyl-3H-imidazo[5,1-f][1,2,4]triazine-4-one dihydrochloride

2-[2-ethoxy-5-(4-ethylpiperazin-1-yl)sulfonyl-phenyl]-5-methyl-7-propyl-1H-imidazo[5,1-f][1,2,4]triazin-4-one

2-[2-ethoxy-5-(4-ethylpiperazin-1-yl)sulfonyl-phenyl]-5-methyl-7-propyl-1H-imidazo[5,1-f][1,2,4]triazin-4-one dihydrochloride

2-[2-ethoxy-5-(4-ethylpiperazin-1-yl)sulfonyl-phenyl]-5-methyl-7-propyl-1H-imidazo[5,1-f][1,2,4]triazin-4-one trihydrate hydrochloride

2-[2-ethoxy-5-(4-ethylpiperazin-1-yl)sulfonyl-phenyl]-5-methyl-7-propyl-1H-imidazo[5,1-f][1,2,4]triazin-4-one; 2-oxidanylpropane-1,2,3-tricarboxylic acid

2-[2-ethoxy-5-(4-ethylpiperazin-1-yl)sulfonylphenyl]-5-methyl-7-propyl-1H-imidazo[5,1-f][1,2,4]triazin-4-one

2-[2-ethoxy-5-(4-ethylpiperazin-1-yl)sulfonylphenyl]-5-methyl-7-propyl-1H-imidazo[5,1-f][1,2,4]triazin-4-one dihydrochloride

2-[2-ethoxy-5-(4-ethylpiperazin-1-yl)sulfonylphenyl]-5-methyl-7-propyl-1H-imidazo[5,1-f][1,2,4]triazin-4-one trihydrate hydrochloride

2-[2-ethoxy-5-(4-ethylpiperazin-1-yl)sulfonylphenyl]-5-methyl-7-propyl-3H-imidazo[5,1-f][1,2,4]triazin-4-one;dihydrochloride

2-[2-ethoxy-5-(4-ethylpiperazine-1-sulfonyl)phenyl]-5-methyl-7-propyl-1H,4H-imidazo[4,3-f][1,2,4]triazin-4-one

2-[2-ethoxy-5-(4ethyl-piperazine-1-sulphonyl)-phenyl]-5-methyl-7-propyl-3h-imidazo[5,1-f][1,2,4]triazine-4-one dihydrochloride

2-[2-ethoxy-5-[(4-ethyl-1-piperazinyl)sulfonyl]phenyl]-5-methyl-7-propyl-1H-imidazo[5,1-f][1,2,4]triazin-4-one trihydrate hydrochloride

2-[2-ethoxy-5-[(4-ethyl-1-piperazinyl)sulfonyl]phenyl]-5-methyl-7-propyl-1H-imidazo[5,1-f][1,2,4]triazin-4-one; 2-hydroxypropane-1,2,3-tricarboxylic acid

2-[2-ethoxy-5-[(4-ethyl-1-piperazinyl)sulfonyl]phenyl]-5-methyl-7-propyl-imidazo[5,1-f][1,2,4]triazin-4-one

2-[2ethoxy-5-(4-ethyl-piperazine-1-sulphonyl)-phenyl]-5-methyl-7-propyl-3h-imidazo[5,1-f][1,2,4]triazin-4-one hydrochloride

2-{2-ethoxy-5-[(4-ethylpiperazin-1-yl)sulfonyl]phenyl}-5-methyl-7-propyl-1H,4H-imidazo[4,3-f][1,2,4]triazin-4-one

2-{2-ethoxy-5-[(4-ethylpiperazin-1-yl)sulfonyl]phenyl}-5-methyl-7-propylimidazo[5,1-f][1,2,4]triazin-4-ol

2-{2-ETHOXY-5-[(4-ETHYLPIPERAZIN-1-YL)SULFONYL]PHENYL}-5-METHYL-7-PROPYLIMIDAZO[5,1-F][1,2,4]TRIAZIN-4(1H)-ONE

2-{2-ethoxy-5-[(4-ethylpiperazine-1-)sulfonyl]phenyl}-5-methyl-7-propyl-3H,4H-imidazo[1,5-a][1,2,4]triazin-4-one

224785-90-4

224785-90-4 (base)

224785-91-5

224789-15-5

224789-15-5 (di-hcl)

224V155

330808-88-3

4-[4-Ethoxy-3-(5-methyl-4-oxo-7-propyl-3,4-dihydro-imidazo[5,1-f][1,2,4]triazin-2-yl)-benzenesulfonyl]-1-ethyl-piperazin-1-ium; chloride

4146AH

4CH-016055

5M8S2CU0TS

5O8R96XMH7

785V904

785V915

789V155

85V904

A816221

A816222

AB0012239

AB00698215-08

AB01274740_02

AB01274740_03

AB01274740-01

AB01275440-01

AB2000617

AC1L3808

AC1L3UZG

AC1OCFGQ

AJ-70562

AK143286

AK143287

AKOS005574038

AKOS015895117

AKOS015966861

AKOS015994765

AKOS022186043

AKOS025312515

AKOS032400217

Ambap224789-15-5

AN-29465

AN-29466

AN-29467

API0004574

API0008769

AS-12621

AS-14122

AT-4121

BAY 38-9456

BAY-38-9456

BAY38-9456

BC677643

BCP0726000254

BDBM14776

BDBM50111900

BRD-K13926615-003-01-7

BSPBio_002392

C23H32N6O4S.ClH.3H2O

C23H32N6O4S.HCl

C23H33ClN6O4S

CAS-1193386-64-9

CCG-101107

CCG-213406

CCG-221149

CHEBI:46295

CHEMBL1339

CHEMBL1520

CHEMBL1874590

CHEMBL2106480

cid_23581791

citric acid;2-[2-ethoxy-5-(4-ethylpiperazino)sulfonyl-phenyl]-5-methyl-7-propyl-1H-imidazo[5,1-f][1,2,4]triazin-4-one

CPD000469155

CS-2548

CS-2765

CTK8E8157

D02731

D03260

D08668

D09989

D0C9SY

DB00862

DR003011

DSSTox_CID_26696

DSSTox_GSID_46696

DSSTox_RID_81830

DTXSID0046696

DTXSID3048318

EC 607-088-5

FT-0631204

FT-0675781

FT-0675782

GS-6519

GTPL7320

HE071086

HMS2052I11

HMS2089K04

HMS2231I08

HMS3371J22

HMS3394I11

HSDB 7304

HY-B0442

HY-B0442A

I06-0385

IF61NL91H3

IMI044

Imidazo[5,1-f][1,2,4]triazin-4(1H)-one, 2-[2-ethoxy-5-[(4-ethyl-1-piperazinyl)sulfonyl]phenyl]-5-methyl-7-propyl-

Imidazo[5,1-f][1,2,4]triazin-4(1H)-one,2-[2-ethoxy-5-[(4-ethyl-1-piperazinyl)sulfonyl]phenyl]-5-methyl-7-propyl-,hydrochloride, hydrate (1:1:3)

IN013972

IN013973

IN014948

J-014730

J-014731

J-014734

KS-00000H95

KS-00000XJE

KS-1318

KS-5073

Levitra (TN)

Levitra hydrochloride

Levitra;Vivanza

LS-111467

LS-181806

MCULE-5211071344

MCULE-5671555647

MFCD08458876

MLS001401365

MLS006011996

MolPort-002-672-272

MolPort-003-666-657

MolPort-003-986-627

MolPort-005-975-775

MolPort-006-167-644

MolPort-009-198-806

MolPort-020-313-423

MolPort-023-220-212

MolPort-027-845-948

NC00357

NCGC00167533-01

NCGC00167533-02

NCGC00167533-03

NOIHTGOGFDFCBN-UHFFFAOYSA-N

NSC-759103

NSC759103

Pharmakon1600-01505374

Piperazine, 1-((3-(1,4-dihydro-5-methyl-4-oxo-7-propylimidazo(5,1-f)(1,2,4)triazin-2-yl)-4-ethoxyphenyl)sulfonyl)-4-ethyl-

Piperazine, 1-((3-(1,4-dihydro-5-methyl-4-oxo-7-propylimidazo(5,1-f)(1,2,4)triazin-2-yl)-4-ethoxyphenyl)sulfonyl)-4-ethyl-, dihydrochloride

Piperazine, 1-((3-(1,4-dihydro-5-methyl-4-oxo-7-propylimidazo(5,1-f)(1,2,4)triazin-2-yl)-4-ethoxyphenyl)sulfonyl)-4-ethyl-, monohydrochloride

piperazine, 1-[[3-(1,4-dihydro-5-methyl-4-oxo-7-propylimidazo[5,1-f][1,2,4]triazin-2-yl)-4-ethoxyphenyl]sulfonyl]-4-ethyl-,monohydrochloride

s2515

SAM001246573

SBI-0206836.P001

SCHEMBL5685

SCHEMBL5772

SCHEMBL973820

SECKRCOLJRRGGV-UHFFFAOYSA-N

SMR000469155

SMR004703549

ST51052749

Staxyn

Staxyn (TN)

STK642629

STOCK6S-20068

TL8001885

Tox21_112530

Tox21_112530_1

UCE6F4125H

UNII-5M8S2CU0TS

UNII-5O8R96XMH7

UNII-IF61NL91H3

UNII-UCE6F4125H

Vardenafil

Vardenafil (hydrochloride)

Vardenafil (INN)

Vardenafil (Vivanza)

Vardenafil [USAN:INN:BAN]

VARDENAFIL CITRATE

Vardenafil dihydrochloride

Vardenafil dihydrochloride [USAN]

Vardenafil Dihydrochloride 1.0 mg/ml in Methanol (as free base)

Vardenafil Dihydrochloride Salt

Vardenafil dihydrochloride solution, 1.0 mg/mL in methanol (as free base), ampule of 1 mL, certified reference material

Vardenafil dihydrochoride (USAN)

Vardenafil HCL

Vardenafil HCl Trihydrate

Vardenafil hydrochloride

Vardenafil hydrochloride (USAN)

Vardenafil hydrochloride [USAN]

Vardenafil hydrochloride hydrate

Vardenafil hydrochloride hydrate (JAN)

Vardenafil hydrochloride trihydrate

Vardenafil Hydrochloride Trihydrate (Vivanza

Vardenafil ODT

VARDENAFIL, LEVITRA

Vardenafildihydrochloride

Vardenafilhydrochloridetrihydrate

VARDENAFILHYDROCHLORIDETRIHYDRATE(SUBJECTTOPATENTFREE)

Vardenafilum

VDN

Vivanza

X5251

XCMULUAPJXCOHI-UHFFFAOYSA-N

Z2790753946

ZINC18324776

US Patents and Regulatory Information for LEVITRA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Bayer Hlthcare	LEVITRA	vardenafil hydrochloride	TABLET;ORAL	021400-003	Aug 19, 2003		DISCN	Yes	No			Y	Y
Bayer Hlthcare	LEVITRA	vardenafil hydrochloride	TABLET;ORAL	021400-001	Aug 19, 2003	AB	RX	Yes	No
Bayer Hlthcare	LEVITRA	vardenafil hydrochloride	TABLET;ORAL	021400-003	Aug 19, 2003		DISCN	Yes	No			Y

Expired US Patents for LEVITRA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Bayer Hlthcare	LEVITRA	vardenafil hydrochloride	TABLET;ORAL	021400-002	Aug 19, 2003
Bayer Hlthcare	LEVITRA	vardenafil hydrochloride	TABLET;ORAL	021400-003	Aug 19, 2003
Bayer Hlthcare	LEVITRA	vardenafil hydrochloride	TABLET;ORAL	021400-004	Aug 19, 2003

Paragraph IV (Patent) Challenges for LEVITRA

Drugname	Dosage	Strength	RLD	Date
	Tablets	2.5 mg
	Tablets	5 mg ad 10 mg
	Tablets	20 mg

International Patents for LEVITRA

Country	Document Number	Estimated Expiration
World Intellectual Property Organization (WIPO)	2004006894
Brazil	9812785
Uruguay	25246